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FDA Updates
07/09/2024

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Inspire Medical Systems, Inc. Removes Inspi...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a revised memorandum (QSO-22-21-CLIA) with details about Final Rule: CMS-3355-F w...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • Clinical Lab

The Joint Commission recently received a six-year renewed laboratory deeming authority approval from the U.S. Centers for Medicare & Medicaid Serv...

Sources:
  • The Joint Commission
Relevant To:
  • Clinical Lab

The Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS) have issued a joint Cybersecurity Advisory (CSA) ...

Sources:
  • Department of Health and Human Services
Relevant To:
  • All Healthcare Organizations

The Joint Commission has released new requirements for their Behavioral Health and Human Services (BHC) accreditation program related to treating opio...

Sources:
  • The Joint Commission
Relevant To:
  • Behavioral Health - Outpatient,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Pharmacy,
  • Behavioral Health - Inpatient,
  • Rural Health Clinics
FDA Updates
06/28/2024

The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities: Ventilator Correction: ZOLL Medical Corpora...

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is encouraging HIPAA covered entities and business associates to ...

Sources:
  • Department of Health and Human Services
Relevant To:
  • All Healthcare Organizations

The Centers for Disease Control and Prevention (CDC) has issued a Health Advisory to notify healthcare providers, public health authorities and the pu...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Clinical Lab,
  • Pharmacy,
  • Rural Health Clinics

The Joint Commission (TJC) has published revisions to requirements for Ambulatory Surgical Centers that are effective August 1, 2024. The changes have...

Sources:
  • The Joint Commission
Relevant To:
  • Ambulatory Surgical Centers

The U.S. Department of Health and Human Services (HHS) has released a final rule that establishes disincentives for health care providers that have co...

Sources:
  • Department of Health and Human Services
Relevant To:
  • All Healthcare Organizations

The U.S. Centers for Disease Control and Prevention (CDC) has free print materials available for patients and health care providers to assist in raisi...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Long Term Care,
  • Rural Health Clinics

The U.S. Centers for Medicare and Medicaid Services (CMS) is warning providers and patients of identified phishing scams for medical records. This may...

Sources:
  • Centers for Medicare and Medicaid Services
Relevant To:
  • All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has published a final rule that establishes certification regulations for certain medical gases and amends...

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Critical Access Hospitals,
  • Hospitals,
  • Long Term Care

The Joint Commission (TJC) recently released a new FAQ about standard IC.07.01.01, which requires hospitals and critical access hospitals to implement...

Sources:
  • The Joint Commission
Relevant To:
  • Critical Access Hospitals,
  • Hospitals

The Centers for Disease Control and Prevention (CDC) has issued a Health Advisory to inform stakeholders about potential disrupted access to care amon...

Sources:
  • Centers for Disease Control and Prevention
Relevant To:
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals,
  • Pharmacy,
  • Rural Health Clinics